CN114432163A - Film and oral care composition comprising the same - Google Patents

Abstract

Films and oral care compositions comprising the films. The present invention relates to films and oral care compositions comprising the films. Described herein is a film for use in an oral care composition comprising: silicon dioxide; a polymer; a natural gum; and particles having a refractive index of about 1.0 to about 2.5; wherein the weight ratio of the polymer to polysaccharide is from about 2: 1 to about 3: 1.

Description

Film and oral care composition comprising the same

technical field

The present invention relates to films and oral care compositions comprising the same.

Background technique

It has been recognized that aesthetic effects play an important role in the consumer acceptance of many products. In many cases, decorative effects have been used to differentiate specific products on the market and to identify products with certain unique characteristics. In the field of dentifrices, substantially clear dentifrice products, such as toothpastes and gels, incorporating contrasting colored flakes therein are known. Such flakes provide consumer satisfaction and facilitate the use of the dentifrice, particularly by children, with aesthetics. While such products have gained consumer acceptance, attempts have been made in the art to further improve the aesthetics and cosmetic and therapeutic benefits of these products to encourage the use of dentifrices in the practice of oral hygiene.

In addition, there are certain ingredients that are known to provide the desired opacity without compromising the toughness and/or stability of the film in the dentifrice. However, certain ingredients known to provide this benefit are associated with undesired effects. Accordingly, there remains a need for additional ingredients that provide a desired aesthetic without compromising the toughness and/or stability of the film in a dentifrice. Certain embodiments of the present invention are designed to meet these and other objectives.

SUMMARY OF THE INVENTION

Some embodiments of the present invention provide a flexible film for use in an oral care composition comprising: silica; a polymer; a natural gum; and particles having a refractive index of about 1.0 to about 2.5; wherein the polymer is The weight ratio of polysaccharide to polysaccharide is from about 2:1 to about 3:1.

Other embodiments of the present invention provide an oral care composition comprising: an orally acceptable carrier; and a plurality of films or film segments, wherein each film or film segment comprises: silica; a refractive index of about 1.5 to about 2.0 particles; a cellulosic material; and a polysaccharide; wherein the cellulosic material and the polysaccharide are present in a weight ratio of about 2.5:1; and wherein the film is substantially free of titanium containing material.

Further embodiments of the present invention provide oral care compositions comprising films as described herein.

Still other embodiments provide methods of using the films and compositions described herein.

Detailed ways

For purposes of illustration, the principles of the present invention have been described with reference to a number of exemplary embodiments of the invention. Although certain embodiments of the invention have been described in detail herein, those of ordinary skill in the art will readily recognize that the same principles are equally applicable to, and can be used in, other apparatus and methods. Before certain embodiments of the invention are described in detail, it is to be understood that the invention, in its application, is not limited to the details of any particular embodiment shown. The terminology used herein is for the purpose of description, not limitation.

As used herein and in the appended claims, unless the context dictates otherwise, a noun without a quantifier modifier means one or more. The singular form of any ingredient class refers not only to one chemical species within that class, but also to a mixture of those chemical species. The terms "a" (or "an"), "one or more" and "at least one" are used interchangeably herein. The terms "including", "including" and "having" are used interchangeably. The term "including" should be interpreted as "including but not limited to". The term "comprising" should be interpreted as "including but not limited to".

是指度，包括角度和摄氏度。Abbreviations and symbols as used herein have their ordinary meanings unless otherwise indicated. The abbreviation "wt%" means weight percent. The notation "μL" refers to microliters or 10 ^-6 liters. symbol

Refers to degrees, including degrees and degrees Celsius.

When referring to a number, the term "about" means any number within 10% of that number. For example, the phrase "about 0.050 wt%" refers to a number between and including 0.04500 wt% and 0.05500 wt%.

As used throughout, ranges are used as shorthand for describing each and every value within the range. Any value within the range can be selected as the endpoint of the range.

The term "mixture" is to be interpreted broadly. It refers to a mixture of ingredients. The mixture can be solid, liquid, semi-solid. If the mixture is a liquid, the mixture may be a solution, an emulsion, a dispersion, a mixture exhibiting the Tyndall effect, or any other homogeneous mixture. In one embodiment, the mixture is storage stable. When referring to a list of ingredients, unless specifically stated otherwise, the term "mixture" refers to mixtures of the aforementioned ingredients with each other, any of the aforementioned ingredients with other ingredients not mentioned above, and several of the aforementioned ingredients with other ingredients not mentioned above A mixture of ingredients. For example, the term "mixture" in the phrase "the source of fluoride is selected from the group consisting of stannous fluoride, sodium fluoride, amine fluoride, sodium monofluorophosphate, and mixtures thereof" refers to any of the following: fluorine A mixture of stannous fluoride and sodium fluoride; or a mixture of stannous fluoride and amine fluoride; or a mixture of stannous fluoride and sodium monofluorophosphate; or a mixture of sodium fluoride and amine fluoride; or sodium fluoride and sodium monofluorophosphate; or a mixture of amine fluoride, sodium monofluorophosphate; or a mixture of stannous fluoride and any other source of fluoride; or a mixture of sodium fluoride and any other source of fluoride; or Mixtures of amines and any other source of fluoride; or mixtures of sodium monofluorophosphate and any other source of fluoride; and other combinations thereof.

Any member of the species list used to exemplify or define a genus may be different from, or overlap with, or be a subset of, or identical to, or nearly the same as, any other member of the species list. the same, or the same. Furthermore, unless expressly stated otherwise, such as when describing the Markush group, the list of species defining or exemplifying the genus is open ended and given that there may be a definition or exemplification of the genus as any other species listed Other species that are better or better than any other species listed.

All references cited herein are hereby incorporated by reference in their entirety. In the event of a conflict between a definition in the present disclosure and that of a cited reference, the present disclosure controls.

When used to describe the present invention, the term "substantially transparent" shall mean translucent or transparent. The term "dentifrice" shall include toothpaste and gel.

In some embodiments, the films described herein may comprise particulate material having a refractive index of about 1.5 to 2; and a cellulosic material (eg, HPMC) and starch, wherein the weight ratio of cellulosic material:starch is about 2.5:1. In some embodiments, the film may also include colorants such as dyes or pigments, flavorants, sweeteners, and/or therapeutic agents such as antibacterial agents or breath fresheners (breath freshening agent).

The size of the film thickness is 0.5 to 10 micrometers, and preferably 2 to 3 micrometers. The dried film of the present invention is then cut or punched into shaped flakes having a particle size of 0.01 to 0.50 inches, preferably 0.08 to 0.25 inches.

具有将恶臭分子(例如硫醇、硫化物和胺)包封在其结构内的能力。合适的气味控制活性物还包括但不限于可以中断产生气味的过程的酶。例如，气味阻断酶例如精氨酸脱亚氨酶可以有效地配制在本发明的组合物中。另外，有效抑制恶臭分子的细菌产生的分子可以用于控制气味，例如干扰细菌酶半胱氨酸脱巯基酶和/或蛋氨酸γ-裂解酶的试剂。适用于气味阻断或作为气味阻断剂的气味控制活性物包括但不限于通过氧化或以其他方式与恶臭分子发生化学反应而起作用的试剂，包括过氧化物、高氯酸盐和具有活化双键的反应性分子。In some embodiments, the oral care composition further comprises an anti-malodor agent. In some embodiments, the additional anti-malodor compounds are known odor control agents. In addition, other metal-containing compounds, such as those of copper, stannous, bismuth, strontium, as well as succulents or other ingredients that enhance salivary flow, act to wash off odors, can be used herein in the composition. Certain strong citrus-based fragrance, odor absorbing compounds that trap or adsorb malodorous molecules can also be used in the claimed compositions. For example, as disclosed, for example, in US Pat. No. 6,664,254,

Has the ability to encapsulate malodorous molecules such as thiols, sulfides and amines within its structure. Suitable odor control actives also include, but are not limited to, enzymes that can interrupt the process of producing odor. For example, odor blocking enzymes such as arginine deiminase can be effectively formulated in the compositions of the present invention. Additionally, bacteria-produced molecules that are effective at inhibiting malodorous molecules can be used to control odor, such as agents that interfere with the bacterial enzymes cysteine dethiolase and/or methionine gamma-lyase. Odor control actives suitable for use in odor blocking or as odor blocking agents include, but are not limited to, agents that act by oxidizing or otherwise chemically reacting with malodor molecules, including peroxides, perchlorates, and Reactive molecules with double bonds.

In some embodiments, the oral care compositions of the present invention comprise a carrier. The carrier can include, but is not limited to, water or other aqueous solvent systems. In some embodiments, the carrier is an orally acceptable carrier. In some embodiments, the orally acceptable carrier may also contain a humectant. Possible emollients are ethanol; polyols including but not limited to glycerol, ethylene glycol, inositol, maltitol, mannitol, sorbitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycols (PEG) and mixtures thereof; or carbohydrates, including but not limited to fructose, glucose, sucrose, and mixtures of carbohydrates (eg, honey).

氯化物(例如十六烷基吡啶

氯化物(CPC)、CPC与锌和/或酶的组合、十四烷基吡啶

氯化物和N-十四烷基-4-乙基吡啶

氯化物)；双胍类，例如氯己定二葡糖酸盐、海克替啶、奥替尼啶、阿来西定；卤化双酚化合物，例如2，2’亚甲基双-(4-氯-6-溴酚)；苯扎氯铵；水杨酰苯胺、溴化度米芬；碘；磺胺类；双双胍类(bisbiguanide)；酚类；哌啶衍生物，例如地莫匹醇和辛哌醇；木兰提取物；麝香草酚；丁香酚；薄荷醇；香叶醇；香芹酚；柠檬醛；桉树脑；儿茶酚；4-烯丙基儿茶酚；己基雷琐酚；水杨酸甲酯；抗生素，例如奥格门汀(augmentin)、阿莫西林、四环素、多西环素、米诺环素、甲硝唑、新霉素、卡那霉素和克林霉素；或其混合物。In other embodiments, the oral care composition may also include an antibacterial agent. In other embodiments, the antimicrobial agent is selected from the group consisting of: triclosan (5-chloro-2-(2,4-dichlorophenoxy)phenol); 8-hydroxyquinoline and salts thereof; zinc or stannous ions Sources such as zinc citrate, zinc sulfate, zinc glycinate, sodium zinc citrate, stannous fluoride, stannous monofluorophosphate and stannous pyrophosphate; copper(II) compounds such as copper(II) chloride, fluorine phthalates, sulfates and hydroxides; phthalic acid and its salts, such as monopotassium magnesium phthalate; sanguinarine; quaternary ammonium compounds, such as alkylpyridines

Chloride (e.g. cetylpyridine

Chloride (CPC), CPC in combination with zinc and/or enzymes, tetradecylpyridine

Chloride and N-tetradecyl-4-ethylpyridine

chloride); biguanides such as chlorhexidine digluconate, hexidine, octenidine, alexidine; halogenated bisphenol compounds such as 2,2'methylenebis-(4- chloro-6-bromophenol); benzalkonium chloride; salicylanilide, dumiphene bromide; iodine; sulfonamides; bisbiguanides; phenols; piperanol; magnolia extract; thymol; eugenol; menthol; geraniol; carvacrol; citral; cineole; catechol; 4-allylcatechol; hexylresorcinol; water Methyl cylate; antibiotics such as augmentin, amoxicillin, tetracycline, doxycycline, minocycline, metronidazole, neomycin, kanamycin, and clindamycin; or a mixture thereof.

In some embodiments, the antibacterial agent is present at a concentration of about 0.001% to about 3% by weight, about 0.05% to about 2% by weight, or about 0.075% to about 1.5% by weight.

In some embodiments, the oral care composition may further comprise anticaries, desensitizers, viscosity modifiers, diluents, surfactants, emulsifiers, foam modifiers, pH modifiers, abrasives, mouthfeel Agents, sweeteners, flavoring agents, coloring agents, preservatives, amino acids, antioxidants, anti-calulus agents, sources of fluoride ions, thickening agents, agents for the prevention or treatment of hard or soft tissues of the oral cavity Active agents, binders, brighteners, and combinations thereof for conditions or disorders. It should be understood that while the general properties of each of the above classes of materials may vary, there may be some common properties and that any given material may serve multiple purposes in two or more such classes of materials . Preferably, the carrier is selected to be compatible with the other ingredients of the composition.

Some embodiments of the present invention optionally comprise amino acids. Suitable amino acids include, but are not limited to, arginine, cysteine, leucine, isoleucine, lysine, alanine, asparagine, aspartate, phenylalanine, Glutamate, glutamic acid, threonine, glutamine, tryptophan, glycine, valine, praline, serine, tyrosine, and histidine and two of them or a combination of more. Amino acids can include R and L forms and their salt forms. Amino acids (and their salt forms) may also include acid esters and/or fatty amide derivatives of amino acids (eg, ethyl lauroyl arginine hydrochloride (ELAH)).

Still other embodiments of the present invention provide oral care compositions comprising antioxidants. Any orally acceptable antioxidant can be used, including butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, herbal antioxidants Oxidants, chlorophyll, melatonin and mixtures thereof.

Other embodiments of the present invention include anti-tartar (tartar control) agents. Suitable antitartar agents include, but are not limited to, phosphates and polyphosphates (eg, pyrophosphates), polyaminopropanesulfonic acid (AMPS), hexametaphosphates, zinc citrate trihydrate, polypeptides, polyolefin sulfonates , Polyolefin phosphates, bisphosphonates. In some embodiments, the antitartar agent is present in an amount from about 0.1% to about 30%. The oral composition may contain a mixture of different antitartar agents. In a preferred embodiment, tetrasodium pyrophosphate (TSPP) and sodium tripolyphosphate (STPP) are used. In some embodiments, the antitartar agent comprises from about 0.1% to about 5% by weight of TSPP. In other embodiments, the antitartar agent comprises from about 0.1% to about 10% by weight of STPP.

Other embodiments of the present invention comprise various dentifrice ingredients, such as surfactants, thickeners or gelling agents, and the like, to adjust the rheology and feel of the composition.

Some embodiments of the present invention provide oral care compositions comprising stannous ions or a source of stannous ions. Suitable stannous ion sources include, but are not limited to, stannous fluoride, other stannous halides such as stannous chloride dihydrate, stannous pyrophosphate, organic stannous carboxylates such as stannous formate, acetate , gluconate, lactate, tartrate, oxalate, malonate and citrate, stannous ethylene glyoxide, etc. One or more sources of stannous ions are optionally and illustratively present in a total amount of about 0.01% to about 10%, such as about 0.1% to about 7% or about 1% to about 5%.

Some embodiments of the present invention provide oral care compositions comprising surface active agents (surfactants). Suitable surfactants include, but are not limited to, water-soluble salts of C8-C20 alkyl sulfates, sulfonated monoglycerides of C8-C20 fatty acids, sarcosinates, taurates, sodium lauryl sulfate, cocoyl Sodium monoglyceride sulfonate, sodium lauryl sarcosinate, sodium lauryl isethionate (sodium lauryl isethionate), sodium laureth carboxylate (sodium laureth carboxylate) and dodecylbenzenesulfonic acid Sodium, and Cocamidopropyl Betaine.

可从Dow化学公司获得)，纤维素聚合物例如羟乙基纤维素、羧甲基纤维素(CMC)及其盐例如CMC钠，天然树胶例如刺梧桐树胶、黄原胶、阿拉伯树胶和西黄蓍胶，胶体硅酸镁铝，以及胶体二氧化硅和/或气相二氧化硅及其混合物。一种或更多种增稠剂任选地以约0.1％至约90％，例如约1％至约50％或约5％至约35％的总量存在。In some embodiments, the oral care composition includes a thickening agent. Any orally acceptable thickening agent may be used, including but not limited to carbomer (also known as carboxyvinyl polymer), carrageenan (also known as Irish moss), and more particularly - carrageenan (ι-carrageenan), high molecular weight polyethylene glycols (e.g.

Available from Dow Chemical Company), cellulosic polymers such as hydroxyethyl cellulose, carboxymethyl cellulose (CMC) and salts thereof such as sodium CMC, natural gums such as karaya, xanthan, acacia, and saffron Gum yarrow, colloidal magnesium aluminum silicate, and colloidal and/or fumed silica and mixtures thereof. One or more thickeners are optionally present in a total amount of from about 0.1% to about 90%, such as from about 1% to about 50% or from about 5% to about 35%.

Other embodiments of the present invention optionally include flavors, sweeteners, colorants, foam regulators, mouthfeel agents, and/or additional other substances in the composition, if desired.

Still other embodiments of the present invention comprise one or more additional active substances operable to prevent or treat a condition or disorder of the hard or soft tissue of the oral cavity, prevent or treat a physiological disorder or condition, or provide a cosmetic benefit . Examples of such additional active ingredients include sialagogues or saliva stimulating agents, antiplaque agents, anti-inflammatory agents and/or desensitizing agents.

Adhesion enhancers can also be added to the oral care compositions, including but not limited to waxes including beeswax, mineral oil, plastisol (a blend of mineral oil and polyethylene), petrolatum, white Petrolatum, shellac, versagel (liquid paraffin, blend of butene/ethylene/styrene hydrogenated copolymer), polyethylene wax, microcrystalline wax, polyisobutylene, polyvinylpyrrolidone/vinyl acetate copolymer, and insoluble Polyacrylate copolymer.

Also effective as adhesion enhancers are liquid hydrophilic polymers, including polyethylene glycols, non-ethylene oxides having the general formula: HOCH2(CH2OCH2)n1CH2OH (where n1 represents the average number of oxyethylene groups). ionic polymer. Polyethylene glycols available from Dow Chemical are represented by numbers such as 200, 300, 400, 600, 2000, which represent the approximate average molecular weight of the polymer, and the formula: HO(C2H4O)a1(C3H6O)b1(C2H4O) A nonionic block copolymer of ethylene oxide and propylene oxide of c1H. The block copolymers are preferably selected (relative to a1, b1, and c1) such that the ethylene oxide component is about 65% to about 75% by weight of the copolymer molecules, and the copolymer has an average molecular weight of about 2,000 to about 15,000 , wherein the copolymer is present in the liquid tooth whitening composition at a concentration such that the composition is liquid at room temperature.

A particularly desirable block copolymer for the practice of this invention is commercially available from BASF and is designated Pluraflo L1220 (PEG/PPG 116/66) and has an average molecular weight of about 9,800. The hydrophilic poly(ethylene oxide) blocks averaged about 65% by weight of the polymer.

(甲基乙烯基醚/马来酸酐)获得，例如AN 139(M.W.500,000)、AN 119(M.W.250,000)；S-97医药级(M.W.700,000)、AN 169(M.W.1,200,000-1,800,000)和AN 179(M.W.高于1,800,000)；其中优选的共聚物是S-97医药级(M.W.700,000)。Synthetic anionic polycarboxylates can also be used in the oral compositions of the present invention as efficacy enhancers for any antibacterial, antitartar, or other active agent used in dentifrice compositions. Such anionic polycarboxylates are typically used in the form of their free acid or preferably partially or preferably fully neutralized water-soluble alkali metal (eg potassium and preferably sodium) or ammonium salts. Preferred are 1:4 to 4:1 copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer, preferably having a molecular weight (MW) of from about 30,000 to about 1,800,000, most preferably from about 30,000 to About 700,000 methyl vinyl ether/maleic anhydride. Examples of these copolymers are available from GAF Corporation under the tradename

(Methyl vinyl ether/maleic anhydride) available as eg AN 139 (MW500,000), AN 119 (MW250,000); S-97 pharmaceutical grade (MW700,000), AN 169 (MW1,200,000-1,800,000) and AN 179 (MW above 1,800,000); the preferred copolymer of which is S-97 pharmaceutical grade (MW 700,000).

When present, the anionic polycarboxylate is used in an amount effective to achieve the desired enhanced efficacy of any antibacterial, antitartar, or other active agent in the oral composition. Typically, the anionic polycarboxylate is present in the oral composition at about 0.05% to about 4% by weight, preferably about 0.5% to about 2.5% by weight.

The adhesion enhancer used in the compositions of various embodiments of the present invention is present in an amount from about 0% to about 20% by weight. Preferably, the adhesion enhancer is present in an amount from about 2% to about 15% by weight.

Some embodiments of the present invention optionally include whitening agents, including, but not limited to, peroxide compounds such as hydrogen peroxide, peroxides of alkali and alkaline earth metals, organic peroxy compounds, peroxyacids, their Pharmaceutically acceptable salts, and mixtures thereof. Alkali metal and alkaline earth metal peroxides include lithium peroxide, potassium peroxide, sodium peroxide, magnesium peroxide, calcium peroxide, barium peroxide, and mixtures thereof. Organic peroxy compounds include urea peroxide (also known as urea hydroperoxide), glyceryl hydroperoxide, alkyl hydroperoxides, dialkyl peroxides, alkyl peroxyacids, peroxyesters, diacyl peroxides oxides, benzoyl peroxides and monoperoxy phthalates, and mixtures thereof. Peroxyacids and salts thereof include organic peroxyacids, such as alkyl peroxyacids; and monoperoxyphthalates and mixtures thereof; and inorganic peroxyacid salts, such as alkali and alkaline earth metals (such as lithium , potassium, sodium, magnesium, calcium and barium) persulfates, dipersulfates, percarbonates, perphosphates, perborates and persilicates, and mixtures thereof. In various embodiments, the peroxide compound includes hydrogen peroxide, carbamide peroxide, sodium percarbonate, and mixtures thereof.

In some embodiments, non-peroxide brighteners may be included in the compositions of the present invention. Brighteners among those useful herein include non-peroxy compounds such as chlorine dioxide, chlorite, and hypochlorite. Chlorites and hypochlorites include chlorites and hypochlorites of alkali metals and alkaline earth metals such as lithium, potassium, sodium, magnesium, calcium and barium. Non-peroxide brighteners also include colorants such as titanium dioxide and hydroxyapatite; pigments; or dyes. In some embodiments, the whitening agent is isolated from the aqueous carrier. In some embodiments, the brightener is separated from the aqueous carrier by encapsulation of the brightener.

In certain embodiments, the composition comprises about 65% to 99.9% of the carrier and further comprises an ingredient, ie, one or more of the following: anticaries, desensitizers, viscosity modifiers, diluents, Surfactants, emulsifiers, foam regulators, pH regulators, abrasives, mouthfeel agents, sweeteners, flavors, colorants, preservatives, amino acids, antioxidants, antitartar agents, fluoride ion sources, thickeners , Active agents, whitening agents, and combinations thereof for the prevention or treatment of conditions or disorders of oral hard or soft tissue. In another embodiment of the composition, the composition comprises from about 80% to 99.5% carrier and further ingredients. In another embodiment of the composition, the composition comprises about 90% to 99% carrier and further ingredients.

In some embodiments, abrasive polishing materials may also be included in the compositions of the present invention. In some embodiments, the abrasive polishing material can be any material that does not excessively abrade the dentin. These materials include, for example, silica (including gels and precipitates), calcium carbonate, dicalcium orthophosphate dihydrate, calcium pyrophosphate, tricalcium phosphate, calcium polymetaphosphate, insoluble sodium polymetaphosphate, hydrated alumina, and resinous abrasive materials such as particulate condensation products of urea and formaldehyde, and other materials such as disclosed in US Patent 3,070,510, issued December 25, 1962 to Cooley et al. (incorporated herein by reference). Mixtures of abrasives can also be used.

In some embodiments, the abrasive system comprises silica. In one embodiment, silica is used as an abrasive. In another embodiment, silica is used as a thickening agent. In yet another embodiment, the oral care composition comprises both abrasive silica and thickening silica.

Silicas suitable for use in the compositions of the present invention can be prepared by any method known in the art or to be developed and, if desired, can be surface modified to improve the ability of the particles to adhere to the tooth surface. Examples can be found, for example, in US Patent Application Publication No. 20070104660, the contents of which are incorporated herein by reference. In embodiments, the silica is present in the composition in an amount of 5% or greater by weight of the total composition. Alternatively, the silica may be present in an amount of 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20% or 25% by weight.

In some embodiments, the silica includes precipitated silica. Precipitated silica is an amorphous form of silica (silicon dioxide, _SiO2 ), which is a white powdery material. Precipitated silica is produced by precipitation from solutions containing silicates. In one embodiment, the production of precipitated silica begins with the reaction of an alkaline silicate solution with a mineral acid. Sulfuric acid and sodium silicate solution were added to the water while stirring, and then precipitation was carried out under alkaline conditions. The choice of agitation, duration of precipitation, rate of addition of reactants, their temperature and concentration, and pH can alter the properties of the silica. The gel phase was avoided by stirring at elevated temperature. The resulting white precipitate was filtered, washed and dried during the manufacturing process.

105-High、

103、

113、

115、

116、

117、

120、

124、

153、

163、

165、

167、

168、

203、

9175；可从W.R.Grace获得的

750二氧化硅、

753二氧化硅、

756二氢化硅

81二氧化硅、

SM 850C二氧化硅、

82二氧化硅、

SM 500T二氧化硅、

SM 614T二氧化硅；可从Solvay获得的

63、

73、

SoftCleanTM、

331、

43；可从PQ Corporation获得的SORBOSIL AC33、SORBOSIL AC43、SORBOSIL BFG10、SORBOSILBFG50、SORBOSIL BFG51、SORBOSIL BFG52、SORBOSIL BFG54、SORBOSIL CBT60S、SORBOSILCBT70、SORBOSIL BFG100。Examples of silicas include those available from Evonik

105-High,

103.

113.

115.

116.

117.

120.

124.

153.

163.

165.

167.

168.

203.

9175; available from WRGrace

750 silica,

753 silica,

756 Silicon Dihydride

81 silica,

SM 850C silica,

82 silica,

SM 500T silica,

SM 614T silica; available from Solvay

63.

73.

SoftCleanTM,

331.

43; SORBOSIL AC33, SORBOSIL AC43, SORBOSIL BFG10, SORBOSIL BFG50, SORBOSIL BFG51, SORBOSIL BFG52, SORBOSIL BFG54, SORBOSIL CBT60S, SORBOSIL CBT70, SORBOSIL BFG100 available from PQ Corporation.

In certain embodiments, the silica comprises Sorbosil AC43 silica available from PQ Corporation. In one embodiment, the properties of AC43 silica include: an average particle size of 2.7 microns to 4.0 microns (as determined by MALVERN MASTERSIZER), a sieve residue of +45 μm, and a maximum moisture loss of 8.0% at 105°C , the ignition loss at 1000°C is a maximum of 14.0%, and the pH in aqueous suspension is 5.5 to 7.5.

165、

163和

153；

200和

22S(可从Evonik获得)；

15和

SM 660(可从W.R.Grace&Co.获得)；

(可从印度Madhu Silica获得)；以及Tixocil 43B(可从Rhodia获得)。In some embodiments, the thickener silica is a high surface area and internal pore volume synthetic amorphous precipitation material to provide a water uptake of about 50ml/20g silica or greater and about 200ml/100g silica or Greater oil absorption (according to ASTM D281 method). Examples of thickener silicas that can be used are

165.

163 and

153;

200 and

22S (available from Evonik);

15 and

SM 660 (available from WR Grace &Co.);

(available from Madhu Silica, India); and Tixocil 43B (available from Rhodia).

In other embodiments, the oral care compositions of the present invention comprise silica particles, for example, having a particle size distribution of 3 to 4 microns; or alternatively, a particle size distribution of 5 to 7 microns; alternatively Typically, the particle size distribution is 3 to 5 microns; alternatively, the particle size distribution is 2 to 5 microns; or alternatively, the particle size distribution is 2 to 4 microns.

Sodium bicarbonate may also be added to the oral care compositions of the present invention. Sodium bicarbonate (also known as baking soda) is a household product with a wide range of uses, including in dentifrices and mouth rinses. It is a white powder, soluble in water, and tends to release carbon dioxide in aqueous systems unless stabilized.

In some embodiments, the compositions of the present invention comprise colorants. In some embodiments, colorants include pigments. As used herein, a "pigment" is a synthetic or natural water-insoluble substance that imparts color to another substance. In some embodiments, the pigment further enhances the whiteness of the teeth. As is known in the art, the visual perception of white matter can be altered by depositing optical brighteners, blue pigments or blue dyes. This effect is often used in laundry detergent products to make white clothes appear "whiter" to the human eye. The same concept has been applied to teeth whitening. See PCT Publication No. WO 2015/099642 to Colgate-Palmolive Company, which is incorporated herein by reference in its entirety.

In other embodiments, the pigment is capable of reflecting enough light that the treated tooth is appreciably whiter than its original color. In some embodiments, the pigments can be tinted such that their natural color is within purplish red to blue-green. More particularly, the pigment may be violet or blue, such as one of those listed in the Color Index International.

In some embodiments, the amount of pigment in the composition may range from 0.01 to 0.075% by weight, such as 0.05%. In other embodiments, the amount of pigment in the composition may be 0.01 to 0.05% by weight, or 0.03% to 0.05% by weight, based on the total amount of the composition. Pigments can be uniformly distributed throughout the composition, or can be dispersed in a second phase such as streaks or other coextruded second phases. Such "biphasic" compositions have the advantage that each phase can be colored differently, thereby providing consumers with a more visually appealing product.

In some embodiments, colorants include dyes. As used herein, the term "dye" refers to an organic substance that is substantially water soluble in aqueous media (wherein the dye remains chemically stable). Dyes for use with the whitening dentifrice compositions of the present disclosure are typically food color additives currently certified for use in food and ingested drugs under the Food Drug & Cosmetic Act, including dyes such as: FD&C Red No. 3 (sodium salt of tetraiodofluorescein), FD&C Yellow No. 5 (sodium salt of 4-p-sulfophenylazo-1-p-sulfophenyl-5-hydroxypyrazole-3 carboxylic acid) , FD&C Yellow No. 6 (sodium salt of p-sulfophenylazo-B-naphthol-6-monosulfonate), FD&C Green No. 3 (4-{[4-(N-ethyl-p-sulfonic acid) Benzylamino)-phenyl]-(4-hydroxy-2-sulfonium-phenyl)-methylene}-[1-N-ethyl-N-p-sulfobenzyl]-Δ-3,5- cyclohexadieneimine] disodium salt), FD&C Blue No. 1 (disodium salt of dibenzyldiethyl-diaminotriphenylmethanol trisulfonic acid anhydride), FD&C Blue No. 2 (indigo blue Sodium salt of sulfonic acid), D&C Green No. 5, D&C Orange No. 5, D&C Red No. 21, D&C Red No. 22, D&C Red No. 27, D&C Red No. 28, D&C Red No. 30, D&C Red No. 40, D&C Yellow No. 10 number, and mixtures thereof in various proportions.

The amount of one or more dyes in the oral care composition can vary widely. For example, the amount of one or more dyes in a whitening dentifrice composition of the present disclosure may be from 0.02% to 2% by weight, or from 0.02% to 1.5% by weight, based on the total amount of the whitening dentifrice composition. , or 0.02 wt% to 1 wt%, or 0.02 wt% to 0.5 wt%, or 0.02 wt% to 0.15 wt%, or 0.02 wt% to 0.1 wt%. In at least one embodiment, the one or more dyes may be uniformly disposed or dispersed throughout the whitening dentifrice composition. In another embodiment, one or more dyes may be arranged or dispersed in different phases of the whitening dentifrice composition. For example, one or more dyes can be disposed or dispersed in the first phase (eg, the hydrophobic phase) of the whitening dentifrice composition, and one or more remaining dyes or no dyes can be disposed or dispersed in the whitening dentifrice composition. in the second phase (eg, hydrophilic phase) of the whitening dentifrice composition.

In some embodiments, the surfactant is selected from the group consisting of water-soluble salts of _C8-20 alkyl sulfates, sulfonated monoglycerides of _C8-20 fatty acids, sarcosinates, taurates, sodium lauryl sulfate , sodium cocoyl monoglyceride sulfonate, sodium lauryl sarcosinate, sodium lauryl isethionate (sodium lauryl isethionate), sodium laureth carboxylate and sodium dodecylbenzene sulfonate , cocamidopropyl betaine, and mixtures thereof.

Additional examples of suitable surfactants include water-soluble salts of higher fatty acid monoglyceride monosulfate, such as the sodium salt of monosulfated monoglyceride of hydrogenated coconut fatty acid; higher alkyl sulfates, such as sodium lauryl sulfate ; Alkylarylsulfonates, such as sodium dodecylbenzenesulfonate; Higher alkylsulfoacetates, such as sodium laurylsulfoacetate; Higher fatty acids of 1,2-dihydroxypropanesulfonate and substantially saturated higher aliphatic acyl amides of lower aliphatic aminocarboxylic acid compounds, such as those having 12 to 16 carbons in the fatty acid, alkyl or acyl group; and the like. Examples of last-mentioned amides include N-lauryl sarcosine, and the sodium, potassium and ethanolamine salts of N-lauryl sarcosine, N-myristoyl sarcosine or N-palmitoyl sarcosine . Also included are, for example, non-anionic polyoxyethylene surfactants, such as Poloxamer 407, Steareth 30, polysorbate 20, and castor oil; and amphoteric surfactants, such as cocamide tegobaine and cocamidopropyl betaine lauryl glucoside; ethylene oxide reacts with and has long hydrocarbon chains (eg, aliphatic chains of 12 to 20 carbon atoms) ) condensation products of various hydrogen-containing compounds containing hydrophilic polyoxyethylene moieties such as poly(ethylene oxide) with fatty acids, fats, alcohols, fatty amides and other fatty moieties, and Condensation products with propylene oxide and polypropylene oxide.

In some embodiments, the viscosity modifier is selected from the group consisting of methylcellulose, hydroxypropylmethylcellulose, hydroxyethylpropylcellulose, hydroxybutylmethylcellulose, carboxymethylcellulose, salts thereof, and mixtures thereof .

)；纤维素聚合物，例如羟乙基纤维素、羧甲基纤维素(CMC)及其盐，例如CMC钠；天然树胶，例如刺梧桐树胶、黄原胶、阿拉伯树胶和西黄蓍胶；以及胶体硅酸镁铝；及其混合物。任选地，基于组合物的重量，这样的另外的增稠剂以约0.1wt％至约50wt％，例如约0.1wt％至约35wt％或约1wt％至约15wt％的总量存在。In other embodiments, the compositions of the present invention may optionally comprise additional orally acceptable thickening agents selected from, but not limited to, one or more of the following: carbomers, also known as carbomers Carboxyvinyl polymers; carrageenan, also known as Irish moss, more particularly carrageenan (iota-carrageenan); high molecular weight polyethylene glycols (eg available from Dow Chemicals) acquired by the company

); cellulosic polymers such as hydroxyethyl cellulose, carboxymethyl cellulose (CMC) and salts thereof, such as sodium CMC; natural gums such as karaya, xanthan, arabic and tragacanth; and colloidal magnesium aluminum silicate; and mixtures thereof. Optionally, such additional thickeners are present in a total amount of about 0.1 wt% to about 50 wt%, eg, about 0.1 wt% to about 35 wt%, or about 1 wt% to about 15 wt%, based on the weight of the composition.

In some embodiments, the compositions of the present invention comprise at least one sweetening agent, which can be used, for example, to enhance the taste of the composition. Any orally acceptable natural or artificial sweetener may be used, including but not limited to: dextrose, sucrose, maltose, dextrin, dry invert sugar, mannose, xylose, ribose, fructose, leucose, galactose , corn syrup (including high fructose corn syrup and corn syrup solids), partially hydrolyzed starch, hydrogenated starch hydrolyzate, sorbitol, mannitol, xylitol, maltitol, isomalt, a Spartan, neotame, saccharin and its salts, dipeptide-based intense sweeteners, cyclamate, and the like.

Still other embodiments provide compositions comprising a sweetener selected from the group consisting of aspartame, acesulfame potassium, Luo Han Guo (Monk fruit) fruit extract, neotame, saccharin, stevia, sucralose, wood Sugar alcohols, advantame, and mixtures thereof.

The total amount of one or more sweeteners present may optionally depend strongly on the particular sweetener chosen, but is typically 0.005 wt.% to 5 wt.% based on the total weight of the composition.

In some embodiments, the composition includes a source of fluoride ions. Sources of fluoride ions include, but are not limited to: stannous fluoride, sodium fluoride, potassium fluoride, potassium monofluorophosphate, sodium monofluorophosphate, ammonium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluorides such as Olaflur (N'-octadecyltrimethylenediamine-N,N,N'-tris(2-ethanol)-dihydrofluoride), ammonium fluoride, and combinations thereof. In certain embodiments, the source of fluoride ions includes stannous fluoride, sodium fluoride, amine fluoride, sodium monofluorophosphate, and mixtures thereof. In certain embodiments, the oral care compositions of the present invention may also comprise a source of fluoride ion sufficient to provide about 50 ppm to about 5000 ppm fluoride ion, such as about 100 ppm to about 1000 ppm, about 200 ppm to about 500 ppm, or about 250 ppm fluoride ion or Provides the composition of fluorine. The source of fluoride ions may be added to the present invention at a level of about 0.001 wt.% to about 10 wt.%, eg, about 0.003 wt.% to about 5 wt.%, 0.01 wt.% to about 1 wt.%, or about 0.05 wt.% in the composition. It should be understood, however, that the weight of the fluoride salt used to provide the appropriate level of fluoride ions varies significantly based on the weight of the counterion in the salt, and such amounts can be readily determined by those skilled in the art.

In some embodiments, the oral care composition is in a form selected from the group consisting of toothpaste; liquid (eg, mouthwash or mouth rinse); gel; spray; or a composition applied to the teeth using a dental tray. In certain embodiments, the composition is in the form of a toothpaste. In some embodiments, the toothpaste is suitable for application to the teeth by brushing. In other embodiments, the oral care compositions are in the form of ingestible solids or non-ingestible solids (eg, tablets or beads).

The films described herein can be stamped into attractive sheets of various shapes, such as hearts, stars, diamonds, and circles.

In some embodiments, the cellulosic material comprises low viscosity hydropropyl methylcellulose (HPMC). When HPMC is used as the film former, it is preferred that the HPMC has a viscosity as determined using an Ubbelohde tube viscometer in a 2% by weight aqueous solution of HPMC at 20°C from about 1 milliPascal second (mPa.s) to about 40mPa.second range. Preferably, the viscosity of the HPMC at 20°C is from about 3 mpa.s to about 20 mpa.s. HPMC is commercially available from Dow Chemical Company under the tradename Methocel E5 LV. Methocel E5 LV is a USP grade low viscosity HPMC with 29.1% methoxy and 9% hydroxypropyl substitution. It is a white or off-white free-flowing dry powder. As a 2 wt. % aqueous solution, its viscosity at 20° C. was 5.1 mPa. sec as measured with an Ubbelohde viscometer.

Pregelatinized cornstarch is commercially available. The preferred starch is available from Cerestar Corporation under the tradename Cerestar Polar Tex-Instant 12640. The Cerestar starch is a pregelatinized, stabilized and cross-linked waxy corn starch. It is readily dispersible and readily swellable in cold water. In its dry form, it is a white, free-flowing powder with an average flake size of no more than 180 microns and 85% of the flakes smaller than 75 microns. Its bulk density is 44 lbs/ ^ft3 .

In some embodiments, the present invention provides a film for use in an oral care composition, the film comprising: a polymer, a clay, a wax, or a combination thereof; and a particulate material having a refractive index of about 1.0 to about 2.5.

In some embodiments, the polymer is selected from the group consisting of: a water-soluble polymer; a water-insoluble polymer; a water-dispersible polymer; and combinations of two or more thereof. In other embodiments, the polymer comprises cellulosic materials, vinyl polymers, acrylate polymers, and combinations of two or more thereof.

In yet other embodiments, the cellulosic material comprises hydroxyalkyl cellulose (eg, hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose, hydroxyethyl cellulose, methyl cellulose, carboxymethyl cellulose) cellulose, and mixtures thereof). In certain embodiments, the vinyl polymer is selected from the group consisting of: polyvinylpyrrolidone; cross-linked polyvinylpyrrolidone; polyvinylpyrrolidone-vinyl acetate copolymer; polyvinyl alcohol; carboxyvinyl polymer; and two or more thereof various combinations.

)、或者其两种或更多种的组合。Still other embodiments provide films wherein the polymer is selected from the group consisting of: polyacrylic acid, polyacrylic polymers, cross-linked polyacrylic polymers, cross-linked polyacrylic acids (eg,

), or a combination of two or more thereof.

In some embodiments, the film comprises natural gums. In other embodiments, the natural gum is selected from the group consisting of: sodium alginate; carrageenan; xanthan gum; gum acacia; arabic gum; guar gum; pullulan; agar chitin; chitosan; pectin; karaya gum; locust bean gum; tragacanth; starch (eg, maltodextrin, amylose, high amylose, corn starch, potato starch, rice starch (rice starch) ), tapioca starch, pea starch, sweet potato starch, barley starch, wheat starch, waxy corn starch, modified starches (e.g. hydroxypropylated high amylose starch), dextrins, levans, cystic fungolans (elsinan), gluten); and combinations of two or more thereof.

In some embodiments, the particulate material is selected from the group consisting of: zinc compounds; calcium compounds; stannous compounds; and combinations of two or more thereof. In yet other embodiments, the particulate material is selected from the group consisting of: zinc oxide; calcium pyrophosphate; dicalcium phosphate dihydrate; calcium carbonate; and stannic oxide. In some embodiments, the particulate material includes calcium pyrophosphate.

In certain embodiments, the refractive index of the particulate material is about 1.1 to about 2.4, optionally about 1.2 to about 2.3, about 1.3 to about 2.2, about 1.4 to about 2.1, about 1.5 to about 2.0, about 1.5 to about 1.9, about 1.5 to about 1.8, about 1.5 to about 1.7, or about 1.5 to about 1.6.

In some embodiments, the polymer comprises a cellulosic material. In yet other embodiments, the film comprises cellulosic material and starch. In other embodiments, the polymer and starch are present in a weight ratio of about 2.5:1.

In some embodiments, the cellulosic material comprises hydroxypropyl methylcellulose. In some embodiments, the cellulosic material is present in an amount from about 1 wt.% to about 20 wt.% based on the total weight of the film. In other embodiments, the cellulosic material is present in an amount from about 5 wt. % to about 15 wt. % based on the total weight of the film. In yet other embodiments, the cellulosic material is present in an amount of about 7.5 wt. % to about 12.5 wt. %, based on the total weight of the film. Still other embodiments provide films wherein the cellulosic material is present in an amount of from about 8 wt. % to about 10 wt. %, based on the total weight of the film. In some embodiments, the cellulosic material is present in an amount of about 9 wt. % based on the total weight of the film.

In certain embodiments, the starch is present in an amount from about 1 wt.% to about 5 wt.% based on the total weight of the film. In some embodiments, the starch is present in an amount from about 2 wt.% to about 4.5 wt.% based on the total weight of the film. In yet other embodiments, the starch is present in an amount from about 3.5 wt.% to about 4.25 wt.% based on the total weight of the film. Still other embodiments provide films wherein the starch is present in an amount of about 3.75 wt. % to about 4 wt. %, based on the total weight of the film.

In some embodiments, the present invention provides films comprising from about 0.1 wt.% to about 20 wt.% particulate material. In other embodiments, the present invention provides films comprising from about 1 wt.% to about 18 wt.%, from about 5 wt.% to about 16 wt.%, or from about 10 wt.% to about 15 wt.% of particulate material. Still other embodiments of the present invention provide films comprising about 15 wt. % particulate material.

In some embodiments, the membrane is substantially free of titanium-containing materials. In other embodiments, the membrane is free of titanium-containing materials. In certain embodiments, the titanium-containing material is selected from titanium dioxide and titanium coated mica.

In some embodiments, the present invention provides films comprising plasticizers. In other embodiments, the present invention provides a plasticizer selected from the group consisting of: glycerin; phthalic derivatives; propylene glycol; low molecular weight polyethylene glycol; and combinations of two or more thereof.

In some embodiments, the present invention provides films with breaking strengths greater than about 750 psi (5,171 kPa). The present invention provides films described herein having a breaking strength greater than about 1,000 psi (6,894 kPa), 1,100 psi (7,584 kPa), greater than about 1,250 psi (8,618 kPa), or greater than about 1,500 psi (10,342 kPa). In various embodiments, the film has a breaking strength of from about 750 psi (5,171 kPa) to about 5,000 psi (34,470 kPa) or from about 750 psi (5,171 kPa) to about 2,900 psi (19,995 kPa).

In certain embodiments, the present invention provides films having a thickness of from about 0.01 mm to about 0.1 mm. In other embodiments, the present invention provides films having a thickness of from about 0.25 mm to about 0.75 mm. In yet other embodiments, the present invention provides films having a thickness of about 0.05 mm.

In some embodiments, the present invention provides oral care compositions comprising any of the films described herein. In some embodiments, the present invention provides oral care compositions comprising films that remain substantially insoluble after about 1 month at 40°C. In some embodiments, the present invention provides oral care compositions comprising films that remain substantially insoluble after about 2 months at 40°C.

In other embodiments, the present invention provides oral care compositions comprising films that remain substantially insoluble after about 1 month at 60°C. In other embodiments, the present invention provides oral care compositions comprising films that remain substantially insoluble after about 2 months at 60°C.

Still other embodiments provide oral care compositions comprising an orally acceptable carrier and a plurality of films or film segments, wherein each film or film segment comprises: particulate matter having a refractive index of about 1.5 to about 2.0; fibers and a polysaccharide; wherein the cellulosic material and the polysaccharide are present in a weight ratio of about 2.5:1; and wherein the film is substantially free of titanium-containing material.

Further embodiments of the present invention provide methods of cleaning the oral surfaces of a mammalian subject comprising applying any of the films or compositions described herein to the oral surfaces of a subject in need thereof. Still other embodiments of the present invention provide methods further comprising the step of irrigating the oral cavity.

Example

The examples and other embodiments described herein are illustrative, and are not intended to limit the full scope of the compositions and methods describing the present disclosure. Equivalent changes, modifications and variations may be made to the specific embodiments, materials, compositions and methods within the scope of the present disclosure with substantially similar results.

Various experiments were conducted to evaluate various properties of the films of the present invention, such as: opacity; toughness; and film stability in toothpaste. The method used to evaluate the membranes and the results resulting from these experiments are described below.

Opacity : L*a*b* of the film was measured using a meter and ΔW was calculated by the following formula: W*=((a*-0)2+(b*-0)2+(L*-100)2 ) 1/2; ΔW=W(film)-W(control). The higher the ΔW score, the better the film opacity. Statistically significant differences were considered to pass or fail qualifying opacity. Neutral means that the ΔW of the sample is lower than the control, but the appearance of the toothpaste is still good.

Toughness: Toughness is primarily defined by the process of stretching the slurry of membranes on the platform. If the membrane is too sticky to stretch out, toughness fails. Meanwhile, the toughness was also evaluated using whether the film was uniformly formed after drying. Only smooth and undamaged films can pass as tough.

Stability in toothpaste : The film was cut into square strips and applied in clear toothpaste at a dose of 0.12%. The toothpaste was then placed in an oven at 60°C for one month to observe the performance of the bars. In the case of poor stability in toothpaste, some strips dissolve in toothpaste after aging. However, some bars remained well in the toothpaste after aging and are mentioned as acceptable in the table below.

Table 1: Natural calcium carbonate

Table 2: Dicalcium Phosphate Dihydrate

dose opacity toughness Stability in TP 0.96% neutral pass dissolve 2% pass pass dissolve 3% pass pass dissolve 5% pass pass dissolve 10% pass fail n/a

Table 3: Calcium Pyrophosphate

dose opacity toughness Stability in TP 0.96% fail pass dissolve 7% neutral pass acceptable 10% pass fail n/a

Table 4: Evaluation of HPMC/starch ratio

Table 5: Dical and Cal Pyro level optimization

10% Dical 15% Dical 15% Cal Pyro HPMC(wt.%) 9.38 9.38 9.38 film opacity high high high Film toughness high high acceptable Membrane stability dissolve dissolve not dissolved

Table 6: Cap Pyro Level Optimization

dose opacity toughness Stability in TP 0.96% fail pass dissolve 7% neutral pass acceptable 10% neutral pass acceptable 15% pass pass acceptable 18% pass fail n/a

Table 7: Tin oxide level optimization

dose opacity toughness 1 month at 60°C 0.5% fail pass n/a 0.96% pass pass pass 3% pass pass pass 5% pass pass pass

While the invention has been described with reference to various embodiments, which have been set forth in considerable detail in order to fully disclose the invention, such embodiments are exemplary only and are not intended to be limiting or representative of the invention Exhaustive enumeration of all aspects. The scope of the invention is determined by the appended claims. Furthermore, it will be apparent to those skilled in the art that many changes can be made in such details without departing from the spirit and principles of the invention.

Claims (52)

1. A flexible film for use in an oral care composition comprising: silica; polymer; natural gums; and particles having a refractive index of about 1.0 to about 2.5; wherein the polymer to polysaccharide weight ratio is from about 2:1 to about 3:1. 2. The film of claim 1, wherein the polymer is selected from the group consisting of: a water-soluble polymer; a water-insoluble polymer; a water-dispersible polymer; and combinations of two or more thereof. 3. The film of claim 2, wherein the polymer comprises a cellulosic material; a vinyl polymer; an acrylic polymer; and combinations of two or more thereof. 4. The film of claim 3, wherein the cellulosic material comprises a hydroxyalkylcellulose (eg, hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose, hydroxyethylcellulose, methylcellulose cellulose, carboxymethyl cellulose, and mixtures thereof). 5. The film of claim 3 or claim 4, wherein the vinyl polymer is selected from the group consisting of: polyvinylpyrrolidone; cross-linked polyvinylpyrrolidone; polyvinylpyrrolidone-vinyl acetate copolymer; polyvinyl alcohol; carboxyl vinyl polymers; and combinations of two or more thereof. 6. The film of any one of claims 3 to 5, wherein the polymer is selected from the group consisting of: polyacrylic acid, polyacrylic polymers, cross-linked polyacrylic polymers, cross-linked polyacrylic acids (eg,

), or a combination of two or more thereof. 7. The film of any preceding claim, wherein the natural gum is selected from the group consisting of: sodium alginate; carrageenan; xanthan; gum arabic; acacia; guar; pullulan; Agar; chitin; chitosan; pectin; karaya gum; locust bean gum; tragacanth; starch (eg, maltodextrin, amylose, high amylose, corn starch, potato starch, rice starch, tapioca and combinations of two or more thereof. 8. The film of any preceding claim, wherein the particles comprise: a zinc compound; a calcium compound; a stannous compound; or a combination of two or more thereof. 9. The film of any preceding claim, wherein the particles comprise: zinc oxide; calcium pyrophosphate; dicalcium phosphate dihydrate; calcium carbonate; tin oxide; or two or more thereof combination. 10. The film of any preceding claim, wherein the particles have a refractive index of about 1.1 to about 2.4, optionally about 1.2 to about 2.3, about 1.3 to about 2.2, about 1.4 to about 2.1, about 1.5 to about 2.0, about 1.5 to about 1.9, about 1.5 to about 1.8, about 1.5 to about 1.7, or about 1.5 to about 1.6. 11. The film of any preceding claim, wherein the polymer comprises a cellulosic material. 12. The film of any preceding claim, wherein the natural gum comprises starch. 13. The film of any preceding claim, wherein the polymer and the natural gum are present in a weight ratio of about 2.8:1. 14. The film of any one of claims 3 to 13, wherein the cellulosic material comprises hydroxypropyl methylcellulose. 15. The film of any one of claims 3 to 14, wherein the cellulosic material is present in an amount of about 1 wt. % to about 20 wt. %, based on the total weight of the film. 16. The film of any one of claims 3 to 15, wherein the cellulosic material is present in an amount of about 5 wt. % to about 15 wt. %, based on the total weight of the film. 17. The film of any one of claims 13 to 16, wherein the cellulosic material is present in an amount of about 7.5 wt.% to about 12.5 wt.%, based on the total weight of the film. 18. The film of any one of claims 3 to 17, wherein the cellulosic material is present in an amount of about 8 wt.% to about 11 wt.%, based on the total weight of the film. 19. The film of any one of claims 3 to 18, wherein the cellulosic material is present in an amount of about 10.5 wt.% to about 11 wt.% (eg 10.73 wt.%) based on the total weight of the film quantity exists. 20. The film of any preceding claim, wherein the natural gum is present in an amount of about 1 wt.% to about 5 wt.%, based on the total weight of the film. 21. The film of any preceding claim, wherein the natural gum is present in an amount of about 2 wt. % to about 4.5 wt. %, based on the total weight of the film. 22. The film of any preceding claim, wherein the natural gum is present in an amount of about 3.5 wt.% to about 4.25 wt.%, based on the total weight of the film. 23. The film of any preceding claim, wherein the natural gum is present in an amount of about 3.75 wt.% to about 4 wt.%, based on the total weight of the film. 24. The film of any preceding claim comprising from about 0.1 wt.% to about 20 wt.% of the particles. 25. The film of any preceding claim comprising about 0.5 wt.% to about 19 wt.%, about 1 wt.% to about 18 wt.%, about 2 wt.% to about 17.5 wt.%, about 3 wt.% % to about 15 wt. %, about 4 wt. % to about or about 10 wt. %, or about 5 wt. % to about 8 wt. % of the particles. 26. The film of any preceding claim comprising about 0.5 wt. %, 1 wt. %, 3 wt. % or about 5 wt. % of the particles. 27. The film of claim 26, wherein the particles comprise a stannous compound. 28. The film of claim 27, wherein the stannous compound is tin oxide. 29. The film of any preceding claim, wherein the silicon dioxide comprises high clean silicon dioxide. 30. The membrane of any preceding claim, wherein the membrane is substantially free of titanium-containing materials. 31. The membrane of any preceding claim, wherein the membrane is free of titanium-containing materials. 32. The membrane of claim 30 or claim 31 , wherein the titanium-containing material is selected from the group consisting of titanium dioxide and titanium-coated mica. 33. The film of any preceding claim, further comprising a plasticizer. 34. The film of claim 33, wherein the plasticizer is selected from the group consisting of: glycerin; phthalic acid derivatives; propylene glycol; low molecular weight polyethylene glycol; and combinations of two or more thereof. 35. The film of any preceding claim, further comprising a fragrance. 36. The film of claim 35, wherein the fragrance comprises menthol or a derivative thereof. 37. The membrane of any preceding claim, wherein the membrane has a breaking strength of greater than about 750 psi. 38. The film of any preceding claim, wherein the film has a thickness of from about 0.01 mm to about 0.1 mm. 39. The film of any preceding claim, wherein the film has a thickness of from about 0.25 mm to about 0.75 mm. 40. The film of any preceding claim, wherein the film has a thickness of about 0.05 mm. 41. The film of any preceding claim, further comprising a colorant. 42. The film of any preceding claim, further comprising an antimicrobial agent. 43. An oral care composition comprising the film of any preceding claim; and an orally acceptable carrier. 44. The oral care composition of claim 43, wherein the film remains substantially insoluble after about 2 months at 40°C. 45. The oral care composition of claim 43 or claim 44, wherein the film remains substantially insoluble after about 1 month at 60°C. 46. An oral care composition comprising: an orally acceptable carrier; and A plurality of membranes or membrane fragments, wherein each membrane or membrane fragment comprises: silica; particles having a refractive index of about 1.5 to about 2.0; Cellulosic material; and polysaccharides; wherein the cellulosic material and the polysaccharide are present in a weight ratio of about 2.5:1; and wherein the membrane is substantially free of titanium-containing materials. 47. The oral care composition of claim 46, wherein the particulate material comprises a poorly soluble stannous compound. 48. The oral care composition of claim 46 or claim 47, wherein the particles comprise tin oxide. 49. The oral care composition of any one of claims 46 to 48, wherein the cellulosic material comprises hydroxypropyl methylcellulose. 50. The oral care composition of any one of claims 46-49, wherein the polysaccharide comprises starch. 51. A method of cleaning the oral surface of a mammalian subject comprising applying the composition of any one of claims 43 to 50 to the oral surface of a subject in need thereof. 52. The method of claim 51, further comprising irrigating the oral cavity.